MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD XP TOTAL KNEE SYSTEM; PROSTHESIS - KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/07/2014

Event Type  Injury  

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Part and lot information for the tibial tray trial unknown.Follow up attempt completed and product information remains unavailable.Part and lot information for the medial bearing trial unknown.Follow up attempt completed and product information remains unavailable.Part and lot information for the lateral bearing trial unknown.Follow up attempt completed and product information remains unavailable.Compatibility search could not be performed as part and lot information unavailable for the listed parts.This device is used for treatment.A complaint history review for the product could not be carried out as the part and lot information remain unavailable even after follow ups have been carried out.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Without the opportunity to examine the complaint product, root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Risks associated with reported condition are addressed in the i/o risk table for vanguard xp as a part of design control risk management.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint: (b)(4).

Event Description

It was reported that during a total knee arthorplasty procedure carried out on (b)(6)2014 on the right knee, the tibial island did not stay intact through full extension during trialing.However, the island was fixed and was secured after the tibial component was cemented/implanted.

• Brand Name: UNKNOWN VANGUARD XP TOTAL KNEE SYSTEM
• Type of Device: PROSTHESIS - KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7072228
• MDR Text Key: 93387104
• Report Number: 0001825034-2017-10717
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73